A study examining the effect of etanercept (Enbrel)on inflammation in the brain.

Phase 1

• Conditions: Mild Cognitive impairment- due to Alzheimer's disease- intermediate likelihood; MedDRA version: 18.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-002145-63-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Inclusion Criteria:

Subjects will have to meet all of the following criteria at screening to enter the study:

1.All subjects must have the capacity to make an informed decision as to whether they would like to take part in this specific clinical research trial.
2.A subject can be male or female and they must be between 50 to 90 years old, inclusive.
3.A subject must have received a minimum of 7 years of formal education.
4.A subject must be able to hear, read, write and perform study neuro-psychological tests in English.
5.A subject must have adequate visual and auditory acuity to allow neuro-psychological testing, based on the research clinician’s judgement.
6.A subject must fulfil the NIA-AA criteria for the diagnosis of Mild Cognitive Impairment due to AD at the screening visit (Albert et al, 2011.) A subject must have a MOCA score of 19 to 25 inclusive at screening, at the discretion of the Principal Investigator.
7.A subject must have a study partner who spends at least eight hours a month with the subject. The study partner may be a close friend or a neighbour and not necessarily a close relative, spouse, son or daughter, and should be present at all visits. Every effort should be made to ensure that the study partner will be the same throughout the study. If it becomes necessary for the study partner to change, the new study partner must satisfy the requirements of this criterion and the change of study partner must be clearly documented.
8.A subject must have been on a stable medication regime for more than 3 months prior to screening.
9.Women of child bearing potential must use adequate contraception to prevent pregnancy during the study and must continue to us contraception for at least four weeks after the last study dose.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Subjects meeting any of the following criteria during screening or baseline will be excluded from the study:

General criteria
1.Inability or refusal to provide informed consent from subject or study partner.
2.Absence of study partner.
3.Unlikely to cooperate in the study, not able to attend scheduled examinations and visits, or not able to follow study instructions, left to the research clinician’s judgement.
4.Participation in another study with administration of any investigational drug in the previous 3 months or already enrolled in another study.
Medical and therapeutic criteria
5.Parkinson’s disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms.
6.Vascular disorder (Modified Hachinski Ischaemic Scale score > 4).
7.Recent Transient Ischaemic Attack (TIA) – within the last 3 months.
8.Signs of major cerebrovascular disease on MRI or CT scan prior to entry into study, (i.e. evidence of an established cortical or basal ganglia infarct).
9.Signs of major cerebrovascular disease on the MRI performed at the screening imaging visit prior to the amyloid and microglial PET scans.
10.Any other previous or ongoing chronic or recurrent disease of the central nervous system, including demyelinating disease or psychiatric diseases, that may have an impact on cognitive performance, left to the research clinician’s judgement.
11.Any of the following laboratory abnormalities at the screening visit:
i)Clinically significant Vitamin B12 levels less than the lower limit of normal.
ii)Clinically significant folate levels less than the lower limit of normal.
iii)Clinically significant thyroid-stimulating hormone (TSH) levels greater than the upper limit of normal and a clinically significant free thyroxine (FT4) level lower than the lower limit of normal.
(Subjects who are successfully treated for folate and vitamin B12 deficiencies or hypothyroidism may be re-screened after 3 months.)
12.Subjects with a previous or present history of severe medical conditions, or medical conditions which are poorly controlled, such as hypertension or diabetes, left to the research clinician’s judgement.
13.History of alcohol or drug dependence or abuse within the last 2 years. Current alcohol >35 units per week for men, or >28 units per week for women, or drug abuse, at the discretion of the research clinician.
14.Surgical intervention planned during the study period.
15.Treatment with immunosuppressive drugs including any systemic corticosteroid drugs. (Topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted.)
16. Treatment with benzodiazepines within a period of three days prior to [11C] (R)-PK-111-95 PET scans imaging.
17.Vaccination or immunization with any live vaccine (e.g.: polio, rubella, yellow fever) within the past 30 days.
18. Pregnancy or breast feeding.
19. Severe hepatic, renal or cardiac disease.
20. Previous use of a TNFa agent.
21. Known skin photosensitivity.
22. Infection in past 4 weeks or active infection.
23. Heart failure: New York Heart Association (NYHA) Grade 3-4.
24. History of blood disorders or current WCC = 3.5 x 109/l; platelet count = 100x109/l; Hb = 10g/dl.
25. Active or latent tuberculosis.
26. Rheumatoid arthritis; psoriasis; psoriatic arthritis or ankylosing spondylitis.
27. Septic arthritis in past 12 months.
28. Sepsis of prosthesis in past 12 months.
29. Chronic leg ulcers.
30. Indwelling urinary catheter.
31

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified